A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

What Was Tested

This registered phase 1 trial tested Semaglutide for high cholesterol and statins.

In this study, four new tablet versions of two compounds will be investigated.

The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.

It had two arms (groups): Part A: Oral semaglutide (experimental) and Part B: NNC0385-0434 (experimental).

Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days.

Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days.

The registry classes the interventions as drug.

Who Took Part

384 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study interventions or related products; any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The high cholesterol and statins participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the high cholesterol and statins participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-11-03 with completion listed for 2023-02-26.

It ran at 2 sites in Canada (1) and Germany (1).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 384 people with high cholesterol and statins.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, High cholesterol and statins research.